Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain (CINS)

NORCE Norwegian Research Centre AS

Status and phase: Completed; Phase 1

Conditions: Chronic Low Back Pain

Treatments: Dietary Supplement: Soy oil; Dietary Supplement: Seal oil; Behavioral: Cognitive Behavioural Therapy; Behavioral: Brief Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00463970

CINS2007

Details and patient eligibility

About

CINS is a large multicentre study which aims to test out the effect of 4 different interventions, namely a brief cognitive intervention (BI), a more extensive cognitive behavioural intervention (CBT), and 2 different nutritional supplementations (seal oil and soy oil) in a population of chronic low back pain patients sicklisted for 2-10 months.

Full description

The treatment principles for low back pain, and also other types of non-specific muscle pain, have changed dramatically over the last 10 to 15 years; from traditional treatment like bed rest and inactivity to more active treatment strategies ("the back pain revolution"; Waddell et al 1997). Norwegian research has been in the forefront, particularly in demonstrating the clinical and cost effective brief interventions (BI) (Indahl et al., 1995, 1998; Hagen et al 2000, 2004, Brox et al 2003, Storheim et al 2003). However, about 30% of the patients do not recover or return to normal social and working life. The aim of this study is therefore to see if a longer cognitive behavioural intervention (CBT) has an additional benefit to BI, and to compare this with a potentially beneficial dietary supplement.

Enrollment: 414 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients sicklisted 2-10 months for low back pain
• The following diagnosis are included: L02, L03, L84 and L86

Exclusion criteria

• Being off the sick list
• Pregnancy
• Osteoporosis
• Cancer
• L diagnoses suggesting recent low back pain trauma
• Specific spinal or other injuries which may account for the current back pain
• Serious psychiatric pathology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

414 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Brief Intervention

Treatment:

Behavioral: Brief Intervention

2

Experimental group

Description:

Cognitive Behavioural Therapy

Treatment:

Behavioral: Cognitive Behavioural Therapy

3

Experimental group

Description:

Seal oil

Treatment:

Dietary Supplement: Seal oil

4

Placebo Comparator group

Description:

Soy oil

Treatment:

Dietary Supplement: Soy oil